Source: FDA, document on fileFDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it.
To check this against FDA, open FDA's record for this establishment on FDA's Data Dashboard, which lists this inspection under FEI 3002984011.
Zydus Lifesciences Limited
Taluka Sanand, Ahmedabad, -, India
Issue DateMay 03, 2019
FEI Number3002984011
CountryIndia
Status
2 Related Warning Letters
Product Type
Drugs
Establishment Type
Finished Pharmaceutical Manufacturer
Sub Systems Impacted
11
Area CleaningBatch RecordsComputer System ValidationContamination ControlEnvironmental MonitoringEquipment CleaningHVACInvestigationsLaboratory ControlsProcess ControlQuality Risk Management
Quality Systems
Quality SystemFacilities & EquipmentLaboratory ControlsProduction System
Zydus Lifesciences Limited FDA Form 483, Taluka Sanand, Ahmedabad, May 3, 2019
